Bisoprolol-ratiopharm( bisoprolol) Instruction:
Manufacturer of the preparation
Tablets 5, 10 mg, 30 tablets in the package
To which is shown Bisoprolol-ratiopharm
The drug is shown to people withfollowing diseases:
arterial hypertension, angina pectoris, postinfarction period, arrhythmias, chronic heart failure( moderately expressed, stable without exacerbation during the last 6 weeks).
How to use bisoprolol-ratiopharm
The drug is taken orally, the therapeutic dose is 5-10 mg once a day, the maximum daily dose is 20 mg.
In patients with impaired renal or hepatic function( creatinine clearance less than 20 ml / min), the dose of Bisoprolol-ratopharm should not exceed 10 mg once a day( this dose can be divided into two).
In elderly patients, dose adjustment is not required.
Use of the drug is recommended to begin with the lowest possible dose.
With the cancellation of the drug, the dose is reduced gradually( every day at half the dose).
Side effects of bisoprolol-ratiopharm
Cardio-vascular system: bradycardia, arterial hypotension( including orthostatic hypotension), rarely - AV conduction slowing or strengthening of AV blockade, arrhythmia, appearance / enhancement of heart failure with worsening of peripheralblood circulation, the course of Raynaud's disease, with the enhancement of the existing intermittent claudication.
From the side of the central nervous system: increased fatigue, unmotivated weakness, dizziness, headache, rarely - a sense of anxiety, irritability, sleep disturbance, depression, confusion( especially in elderly patients), bright dreams, depression.
On the part of the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain, constipation, increased level of hepatic enzymes( ASAT, ALT), hepatitis.
On the part of the respiratory system: rhinitis, dyspnea, bronchospasm( especially in patients with asthma or obstructive bronchial diseases in the anamnesis);
Skin reactions: rash.
From the side of the hearing: hearing loss.
On the part of the organs of vision: dry eyes, pain in the eyes, conjunctivitis.
Metabolic disorders: increased TG levels, hypoglycemia. Patients with a latent form of diabetes mellitus or manifestation of this disease may decrease glucose tolerance, masking manifestations of hypoglycemia.
There are reports of increased symptoms of psoriasis or the occurrence of psoriasis-like rashes.
In isolated cases, alopecia, tinnitus, weight gain, emotional lability, temporary memory loss, allergic rhinitis, hypersensitivity reactions, autoimmune disorders such as systemic lupus, decreased sexual function, dysuria, impairmenttaste, nonspecific disorders - muscle weakness, convulsions, pain in the muscles and joints.
The drug is used with caution in patients with grade I AV blockade, cardiac and peripheral circulatory disorders, including with Raynaud's disease and metabolic acidosis.
β-adrenoreceptor blockers can provoke or increase the frequency and duration of attacks of vasospastic angina / angina Prinzmetal.
Patients with COPD should not be prescribed or, if necessary, used in lower doses( initial dose - 2.5 mg / day) in combination with bronchodilators.
With caution apply the drug in patients with diabetes mellitus with significant fluctuations in the level of glycemia and metabolic acidosis. For treatment of patients with severe form of pheochromocytoma, the drug is used only in combination with β-adrenoreceptor blockers. Bisoprolol-ratopharm may mask symptoms of thyrotoxicosis or hypoglycemia.
At a heart rate of ≤50-55 bpm in 1 min, the dose of the drug should be reduced.
With congestive heart failure, it is necessary to evaluate the benefit / risk ratio in view of the possible inhibition of myocardial contractility. Treatment begins with a minimum dose of 2.5 mg.
Bisoprolol-ratiopharmum should be used with caution in patients with psoriasis, including history.
The drug may increase sensitivity to allergens and the severity of allergic reactions.
Patients with CHD with sudden withdrawal of the drug may develop withdrawal syndrome. Therefore, the abolition of the drug and a reduction in the dose should be carried out gradually.
Each tablet contains about 130 mg of lactose, each recommended dose contains 130-260 mg of lactose, which patients should be warned with galactoseemia or glucose / galactose absorption disorder syndrome.
The drug gives a positive result in the conduct of doping control.
During pregnancy, the use of the drug is possible only after a thorough assessment of the benefit / risk ratio for the mother and fetus. Given the lack of information on the content of the drug in breast milk, its use during breastfeeding is not recommended.
The drug should not be administered to children under 12 years of age due to lack of experience.
The drug does not affect the ability to drive vehicles or other mechanisms, but due to possible individual reactions when using the drug( especially at the beginning of treatment), care must be taken.
Contraindications to the drug prodrug are:
hypersensitivity to bisoprolol or other components of the drug, chronic heart failure in the phase of decompensation, cardiogenic shock, II-III degree AV blockade, sinus node weakness syndrome, sinoatrial blockade of degree II, bradycardia( heart rate ≤50 bpm), propensity to bronchospasm( BA, obstructive airway disease), arterial hypotension( systolic BP ≤90 mm Hg), late stages impairedI peripheral circulation, the simultaneous use of MAO inhibitors( except MAO-B), age 12 years.
Interaction of Bisoprolol - Ratiopharma
Combinations( due to the possibility of decreased activity) are contraindicated with floktaphenin, sultopride, MAO inhibitors( except MAO-B).
Allergens used for immunotherapy, allergen extracts for skin tests in combination with β-adrenoreceptor blockers can provoke the development of severe systemic allergic reactions.
Combinations of bisoprolol with calcium antagonists( verapamil, diltiazem, bepridil) are not recommended / particularly necessary due to an increase in the negative effect on the inotropic function of the myocardium, AV-conduction, blood pressure.
Drugs containing clonidine, reserpine, alpha-methyldopa, should not be given concomitantly with bisoprolol because of a possible slowdown in heart rate.
Clonidine, digitalis, guanfacin can inhibit AV-conduction.
If bisoprolol combined therapy with clonidine is abolished, after treatment with clonidine has been discontinued, bisoprolol treatment should continue for several more days, providing medical supervision of the patient's condition.
Combinations requiring caution: Class I antiarrhythmics( eg, disopyramide, quinidine, lidocaine, difenin, propafenone);antiarrhythmic drugs of class III( amiodarone, sotalol);calcium antagonists( dihydropyridine derivatives) - due to increased risk of developing arterial hypotension and heart failure.
The effect of insulin and oral hypoglycemic drugs may be enhanced with simultaneous use with bisoprolol.
Cardiac glycosides: decrease in heart rate, lengthening AV-conduction.
Baclofen: increased antihypertensive activity.
Contrast preparations containing iodine: β-adrenoreceptor blockers may increase the risk of anaphylactic reactions.
Drugs that block the synthesis of prostaglandins( in particular NSAIDs): a reduction in the antihypertensive effect.
Derivatives of ergotamine: exacerbation of peripheral circulatory disorders.
Sympathomimetic drugs: Combination with bisoprolol may reduce the effects of both drugs.
Tricyclic antidepressants, barbiturates, phenothiazines, other antihypertensive drugs: increasing the effect of reducing blood pressure.
Antihypertensives( diuretics, ACE inhibitors, β-adrenoreceptor blockers) and nitrates potentiate the antihypertensive effect of bisoprolol.
Corticosteroids: a decrease in the antihypertensive effect due to delay in water and sodium is possible.
Means for inhalation anesthesia, hydrocarbon derivatives( chloroform, cyclopropane, halothane, methoxyfuran, etc.) with simultaneous use with β-adrenoreceptor blockers increase the risk of oppression of myocardial function and the development of hypotensive reactions. The effect of depolarizing neuromuscular blockers may increase and elongate under the influence of β-adrenoreceptor blockers.
Cimetidine can reduce the clearance of β-adrenoreceptor blockers that are metabolized in the liver and, accordingly, increase their bioavailability.
The simultaneous use of rifampicin somewhat speeds up the metabolism of bisoprolol, however, in such a situation, there is no need to adjust the dose of the drug.
Xanthines( aminophylline, theophylline) can interdepend the therapeutic effects when combined with β-adrenergic blockers.
It is manifested by bradycardia, arterial hypotension, heart failure, arrhythmia, bronchospasm, respiratory failure, acrocyanosis, seizures.